On Friday, 28 November 2014, CBC Marketplace aired an episode (which I recommend watching before reading this) in which they sent parents and their babies to homeopaths for vaccine advice. They were exploring whether homeopaths were one of the sources of misinformation scaring concerned parents away from vaccines.

Homeopaths are certainly not the only source of vaccine misinformation, or even the primary source, but as purported alternative health care providers, they have earned additional scrutiny. Within the context of the provision of health advice, their statements were shocking and deeply troubling, especially considering gaps in regulation of their remedies and the profession as a whole. Also disturbing was the use of autism — a supposedly vaccine-linked condition (it is not) — as a scare factor, contributing to stigma against people with autism, and the confidence and authority with which they made statements that are factually incorrect.

We are not entitled to our own facts; an aside on ethics…

This is the context in which I object to the current practice of homeopathy. The problem is more than the vaccine claims. The problem is that, despite those that have good intentions, the practice of homeopathy is far below the quality of service that Canadians should expect to receive from health practitioners and there are insufficient protections in place to ensure accountability and safety.

A patient/client has a right to informed consent, which means that any information or recommendations provided to them must be accurate (i.e., based on the highest quality evidence currently available), objective, non-judgemental, and appropriate/relevant. The client (or a substitute decision-maker) must also demonstrate reasonable understanding of the information and must unambiguously agree to recommendations, otherwise the treatment cannot ethically proceed. The practitioner must be accountable for their recommendations and maintain appropriate documentation. This is the basis of all health care interactions.

The erroneous statements made by the homeopaths in the Marketplace piece demonstrate that at least some homeopaths, regardless of their good intentions, are not ready for even this basic level of practitioner responsibility. The subsequent public responses on social media and the alleged deletion of information from websites without public acknowledgement also demonstrates a concerning lack of accountability. Finally, the accusations of conspiracy are beyond the pale for a health practitioner.

Homeopaths are not ready to be health care practitioners — a demonstration:

Homeopaths, and people who use homeopathy services, were apparently incensed and angrily took to Twitter and Facebook during and after the program aired. The vast majority of the response focused on having been secretly taped and conspiracy theories that Erica Johnson, Marketplace, CBC, and Health Canada are Big Pharma shills who target homeopaths. Many respondents retweeted each other and shared the same articles.

Keep the following in mind when considering the responses of homeopaths to CBC Marketplace:

Homeopaths and their respective organizations have failed to provide an adequate response to Marketplace that demonstrates appropriate professional accountability. Since the program aired, there has been no reassurance from the schools or organizations promising education to their members to ensure that future client interactions will be in line with public health recommendations. Many homeopaths still continue to claim that nosodes are as effective as vaccines, despite this statement from the Canadian Homeopathic Pharmaceutical Association (CHPA): “Our association and its members cannot recommend the use of any homeopathic medication, in lieu of conventional medical vaccinations. To our knowledge there have been no homeopathic substances thoroughly tested as consistently effective replacement therapeutics for conventional medical vaccinations.”

Health Canada does not recommend nosodes being used as vaccine alternatives (manufactured nosodes now require a warning label saying as much), but they lack authority over what homeopaths do/say. Lack of authority to act does not mean that they counter-intuitively approve of compounded nosodes (which are nosodes that the homeopaths prepared themselves).

I will highlight a few responses:

Beth Landau-Halpern wrote a blog post called “A Shot of Deceit” in which she took issue with Marketplace’s clandestine methods of data collection and stated that she is not sure which lawful circumstance(s) she met to be secretly taped (hint, they are in Beth’s article: “abuse of trust” and “no other way to get the information”). She likened her interaction with the patient as “bully” tactics, because the patient asked for a remedy for measles before leaving and Beth obliged. The implication is that she was pressured into giving the remedy, which made her look bad.

But a healthcare practitioner operates within their scope of practice and code of ethics at all times. If Beth thought it wouldn’t be appropriate to provide the remedy to “Emma” at that time, she shouldn’t have done so. So either Beth thought it was appropriate, or she allowed a patient to “bully” her into providing an inappropriate treatment. Neither circumstance is a demonstration of competence on Beth’s part, so I fail to see how this is a criticism of Marketplace or a defense of her actions.

She also threatened CBC with libel before the show aired and, as Scott Gavura discusses here, she gloated about the response from Health Canada regarding her paternalistic lack of warning to the patient and Marketplace’s subsequent complaint. The implication is that the Marketplace complaint was dismissed because it was spurious, and Beth takes the dismissal as “clearance” (i.e., that Health Canada agrees with her), when in fact it was routine bureaucracy.

Laurie J. Willberg has shared many links on Facebook and Twitter — before and after Marketplace aired — claiming vaccines are deadly, toxic, and ineffective while also claiming that homeopathy can treat or cure deadly diseases (such as whooping cough, dengue fever, meningococcal, chikungunya, cholera, ebola, etc). She has linked to known anti-vaccination organizations such as NVIC and VRAN and known anti-vaccine proponents such as Joe Mercola and the Health Ranger. Following the Marketplace piece, she tweeted prolifically about homeopathy “skeptics” (always in scare quotes, often with links to Skeptical About Skeptics), exposing an interpretive framework of persecution and battle. She directly responded to the Marketplace piece thusly:

She has so far not provided any justification for her stance on nosodes and vaccines being contrary to the CHPA, Health Canada, and the government of Ontario. I also fail to see how recording statements during a clinical interaction is “entrapment”, as no homeopaths were incited by Marketplace to commit a criminal offense.

Sonya McLeod, judging from her tweets and Facebook page, has apparently also decided that anyone who disagrees with her is part of a conspiracy that spans everyone working in public health, CBC, WHO, the Canadian government, and anyone else who supports vaccines. She tweeted a blog post by Karen Wehrstein listing some studies to demonstrate that homeopathy is effective, yet concluding in the final paragraph that “It’s not scientific per se, but the popularity of homeopathy around the world is testament to its effectiveness.”

So even the Canadian Consumers Centre for Homeopathy concluded that there is no compelling evidence. If I were to base my professional conduct on popularity rather than actual evidence, I’d never prescribe exercise again.

Before and after Marketplace aired, Sonya shared and composed pro-nosode and anti-vaccine tweets. She has also since bragged about blocking “homeopathy skeptics”, indicating an unwillingness to consider evidence contrary to her beliefs. Sonya responded directly to Marketplace thusly:

This is an inadequate response to the significant professional and public health issues exposed by CBC and an inadequate defense of recommending nosodes, despite the stance of the CHPA. Health practitioners are obliged by professional ethics to change their practice, if necessary, based on evidence to ensure best practice for the client. Sonya blocks out any disagreement, demonstrating an inappropriate and unethical relationship with evidence with respect to client care.

Access Natural Healing Holistic Health Centre set up a Facebook page several years ago with the apparent intent of allowing homeopaths to warn each other of CBC investigations (e.g., past posts to the page show shares/posts of CBC ombudsman complaints) in addition to general information about homeopathy. The comments and a link to a blog post from 29 September 2014 seem to indicate that homeopaths felt burned by another Marketplace special on homeopathy from 2011 (Cure or Con) and were distrustful of them the second time around.

A post from 25 August 2014 indicates that a producer from CBC Marketplace contacted a homeopath named Elena Cecchetto of Access Natural Healing via email following a visit and follow-up phone call. The post alleges that CBC never contacted them before the email and that “Erica Johnson of Marketplace is at it again”. The email states that CBC visited the clinic and documented their interaction with Elena, during which it was claimed that nosodes were “over 90% effective”. CBC then invited her to speak to them on camera about their findings. In the comments, Elena indicated that the same letter was sent to Sonya McLeod and Beth Landau-Halpern indicated she got the letter as well.

This indicates that at least 3 months passed between Marketplace’s initial investigations and airing their show, but during that time none the homeopaths that were contacted agreed to speak to them about their evidence. Now, if I believed I was being set up, I probably wouldn’t want to be on CBC Marketplace either. But 3 months is plenty of time to organize an independent rebuttal demonstrating conclusively that there is sufficient evidence to support their clinical recommendations and claims about vaccines. They have not done so.

Susan Drury responded to Marketplace in an email bulletin, accusing them of cherry-picking and again taking issue with being secretly filmed. She does not provide supportive clinical evidence or specifically address how she was cherry-picked.

Conclusion

I believe that most homeopaths truly do want to help people. But without proper oversight and guidance, they are putting their much-admired desire to help people to disappointing use and are exceeding Health Canada’s ability (or willingness) to reign in their potentially damaging clinical recommendations.

Homeopaths’ main complaints with CBC Marketplace seem to be:

They were secretly taped, which is deceit, entrapment, etc. (as contextualized by the overwhelming focus of their responses).

They were misrepresented or taken out of context.

The show did not provide false balance about vaccine shortcomings (and they don’t mean known shortcomings like vaccines not being 100% effective or the risk to people with egg allergies, etc.; they mean the unproven “shortcomings” of having killed children or caused autism — as contextualized by their social media links and claims).

CBC Marketplace are Big Pharma shills and their show was propaganda.

Here is my response to each of these complaints:

A health professional should be able to stand by their recommendations, because they should be clinically justified. The same client interaction should take place with or without a camera.

The Marketplace footage shows full, naturally-occurring statements that are factually incorrect and contrary to public health recommendations. Homeopaths have not adequately addressed the factual inaccuracy of their statements. Rather, many have continued to make pro-nosode and anti-vaccination statements on their personal social media accounts, while at the same time claiming the Marketplace piece was biased and deceitful.

I have yet to see a single adequate response that directly and clearly justifies their clinical reasoning in providing advice that is contrary to public health recommendations and their own pharmaceutical association regarding nosodes and vaccines.

If Marketplace are shills for Big Pharma, then who is CHPA shilling for? Homeopaths have a conflict of interest, in that they stand to gain financially by vilifying mainstream medicine and selling their own remedies in addition to the cost of a consultation (for example), yet they have accused CBC Marketplace (and anyone else who accepts public health recommendations that run counter to homeopathic advice) of being government and Big Pharma shills spreading propaganda. It is not propaganda to carefully consider evidence and present an appropriate conclusion.

If homeopaths want to act as health professionals, they must also accept the responsibilities of health professionals including obtaining informed consent, having professional accountability, minimizing and disclosing relevant conflicts of interest, providing robust supporting evidence for clinical decisions, and changing their clinical practice as evidence dictates. The responses of homeopaths so far have not sufficiently met any of these criteria.

This is a guest post by Laura Creek Newman, RD, critically examining health claims about infant formula made by Meghan Telpner, “Nutritionista”, in her recent article What’s Lurking In That Baby Formula?

I am going to preface this with my background. I am a registered dietitian practicing for four years, largely in all areas of adult health. I am not an infant feeding expert, though I have recently been working in pediatrics and did have significant and evidence-based training in the area through my schooling and internship. I am also a mom of a 17-month-old; a mom who breastfed exclusively for six month and continued past a year. I am also a mom who had trouble breastfeeding and could not pump enough to bottle feed once I went back to work. I’m a mom who used formula. From my training and my own experiences feeding my daughter I do not belong to any particular camp: I believe breast is great when you can, but ultimately a baby needs to eat and baby formulas are the next best thing.

First off, I want to clarify something: genetically modified organisms (or GMOs) are everywhere. They are the bread we buy, the animals we eat, the vegetables I planted in my garden. All of them. No, I don’t work for Monsanto. Pretty much every food crop humans have cultivated since humans learned to cultivate crops is genetically modified. This is due to selective breeding at the hands of skilled farmers or gardeners who cross-bred different plants or animals to create new varieties. They breed together organisms that have the same desirable characteristics for many generations until they reliably get a new strain of that organism. For example, say you have red petunias and white petunias, but you want pink. One would breed the red and white together; if some flowers come out pink, you would take those and breed them together, but you wouldn’t breed them with the flowers that turned out white or red. Over time, one will get more and more pink flowers until they’re all pink. And voila! You’ve created a new strain of pink petunia. You can thank these millennia-old techniques for helping produce strawberries, bananas, and the dozens of varieties of peppers and heirloom tomatoes we happily devour today. Our rapid technological advances in the last half century, particularly decoding the genomes of many organisms, have allowed us to speed up this process by picking out and only planting seeds that carry the desired genetic traits while leaving the rest. We have also been able to modify some of the traits in the lab to improve disease resistance, remove toxic substances, and improve the nutritional profile of foods. It is this latter part that has some people scared of “frankenfoods”. Would these plants “naturally” have genes that make them super-resistant to drought, for example? Perhaps not. The important question to ask is: does this change in the genetic structure make the food unsafe? (The answer is no). This article gives a good overview of the subject. Whether you choose “organic” or not, your food definitely has been genetically modified somewhere through its history before arriving on your plate.

This brings me back to the article at hand. It is listed under the category “healthwashing” on the website. The author posits that most of the ingredients in conventional baby formulas, even many organic baby formulas, are unhealthy, thus making these products unfit for baby. While formula companies have used (and may still use) unethical marketing practices, this does not comment on the safety of their products. Infant formulas are some of the most heavily regulated and monitored food products (source, source) in the United States (similarly in Canada). There are several erroneous and potentially harmful comments made in this article and I would like to address them.

Human breast milk is our best way to understand an infant’s nutritional needs. Breast milk contains about 42% carbohydrate as lactose (milk sugar), 50% fat (as a mixture of fatty acids, mainly palmitic acid), and about 7% protein with 67 kcal/100 mL (source: Krause’s Food, Nutrition, and Diet Therapy 11th Edition, Mahan, L.K. & Escott-Stump, S., 2004, 8:221). From this, we assume that this is what infants require to grow properly, so infant formulas are designed to mimic as closely as possible this nutrient profile. In contrast, cow’s milk contains 30% carbohydrate, 50% fat, and 20% protein, and also has 67 kcal/100 mL (ibid.); soy milk contains 21% carbohydrates, 44% fat, and 35% protein with 33 kcal/100 mL (source). Cow’s milk is chosen as the primary base for infant formulas due to its similar nutrient and caloric profile to human milk. However, it requires processing and additional ingredients (particularly carbohydrates, vitamins, and minerals) to make it safe and appropriate for human babies.

The author first highlights an ingredient list for a soy-based formula from Similac: the author notes the first ingredient is corn syrup solids, the second is “genetically modified protein”.

This infant formula contains 42.6% corn syrup solids, followed by genetically modified protein. You wouldn’t eat that. If you can choose another option, choose another option!

It is unclear if the protein is in fact genetically modified, but as demonstrated above, this is likely not a safety issue. Soy protein isolate is protein extracted from soy meal that is 90% pure: this means that it is at least 90% soy protein with very little fat and carbohydrate. Infants do not require as much protein as adults and too much can be detrimental, so formula manufacturers use this product to most accurately control the proportion of protein in the final product. As for corn syrup solids, they “are defined by the FDA as dried glucose syrup (in which the reducing sugar content is 20 DE or higher. Corn syrup solids are generally recognized as safe (GRAS) as direct human food ingredients at levels consistent with current good manufacturing practices (21 CFR 184.1865).” (Source.) In essence, it is dehydrated corn syrup where the sugars are glucose and short glucose chains. It has a relatively low sweetness level compared to sucrose (corn syrup solids: 23–28, sucrose: 100). By comparison, lactose (milk sugar) has a sweetness level of about 16 (source), so corn syrup solids are slightly sweeter but comparable. Some type of sugar (short molecules) is needed for the carbohydrate source as it is harder for babies to digest starches (large molecules) and they get the energy too slowly, which can slow down their growth. As this example is of a soy-based formula, the manufacturer has to use a plant-based carbohydrate instead of lactose to make it appropriate for babies with lactose intolerance, galactosemia, and vegan/vegetarian babies*. As for the author’s comment “you wouldn’t eat that”, well, the reader probably wouldn’t eat/drink many things that an infant would, including any infant formula or breast milk. What one adult may or may not eat or find appealing is entirely subjective and not a useful commentary on infant nutritional products.

The second formula discussed by the author is Nestle Good Start, a standard infant formula and industry leader. The comments are as follows:

Partially hydrolized whey protein: Whey protein comes from cow’s milk, which is one of the most common food allergies in children. Allergic reactions can include diarrhea, hives and swelling of the lips.

See above for why cow’s milk is used as the base for most infant formula. It is true that it is the most common allergen among children, however, it is also one of the most likely allergies to be outgrown by the child’s fifth birthday, unlike peanuts, tree nuts, and shellfish, which also make the list.

Corn maltodextrin: Corn maltodextrin is a food additive often found in snack foods like chips and crackers. Given that 80% of corn grown in Canada is genetically modified, it’s safe to assume that this cheap food additive comes from GMO corn and not the organic kind. It’s also a sweetener.

See above for the issues around GMO foods; there is no evidence to show that GMO-derived ingredients are hazardous to health. Organic maltodextrins are also available. Maltodextrins are short-to-medium starch molecules (up to 20 glucose molecules per chain) made by a similar process to corn syrup solids (source, source). The sweetness varies from no sweetness to mildly sweet; the relative sweetness factor ranges from 6–21 (recall that the sweetness of lactose is 16). For this reason, maltodextrins are not primarily sweeteners and may not impart any sweet taste to a food at all. The primary characteristics of maltodextrins are: high solubility, easy and rapid digestibility (high glycemic index), low sweetness, provision of smooth and full texture to foods (source, source). The author is correct that this ingredient is heavily used in many processed foods, particularly in the “snack foods and beverages” category. She is also correct that this is a “cheap” (inexpensive) ingredient. However, as the skeptics’ mantra states: correlation does not equal causation; the presence of this ingredient in a snack food does not demonize that single ingredient. In the same vein, if water, bananas, or organic rolled oats appear as ingredients in a “junk” food, it does not mean that any of those things are inherently bad or unhealthy. Maltodextrins have found their way into baby formula for several reasons. First, they are inexpensive, and it would be naïve to deny that food manufacturing companies are not continuously looking for lower cost ingredients. Second, and most importantly, the aforementioned characteristics of these starches are very desirable for a baby formula. Their high solubility means that powdered formula will dissolve easily and fully without lumps; this makes it easier and tastier for a baby to drink. The fast and easy digestion is easier on a baby’s developing intestines than regular starches and gives baby the quick energy he or she needs. The low sweetness factor makes the formula taste more like breast milk and helps avoid getting babies hooked on the really sweet flavour that comes from other sweeteners like honey, maltose, and sugar.

Soybean oil: Soybean oil is cheap, which means it’s found in virtually all processed foods. Like corn, unless otherwise noted, it most likely comes from GMO sources. It’s a highly unstable oil, so food manufacturers partially hydrogenate it to raise the melting point and stabilize it so it won’t turn rancid. The result? An altered chemical structure and, in many cases, trans fats.

Again, see above for safety concerns around GMO foods. The author is correct again in noting that, like corn and corn-based ingredients, soy is an inexpensive ingredient, and likely the cheapest source of fat available (partially due to high subsidies to producers). Historically, soybean oil was hydrogenated to make it more stable, and this had the negative side effect of increasing trans-fats (which are known to increase LDL cholesterol, decrease HDL cholesterol, and increase risk for cardiovascular disease). Since label reporting of trans-fats in foods and ingredients became mandatory in 2006, food producers have generally moved to breeding low linolenic acid varieties of soy that produce a more stable oil without hydrogenation (source, source). Further to this, hydrogenated oils are not allowed to be used in infant formulas 14. Similarly to breast milk, infant formula does contain a small amount of trans-fat (around 2–3%; source, source) but a large portion of this is naturally occurring from cow’s milk (gut microbes in cows produce a small amount of trans-fat during digestion that is passed on to cow’s milk). Thus, it is unlikely that infant formulas contain much, if any, commercially hydrogenated trans-fats.

Palm olein: Research has shown that babies can’t properly digest palm oil — in fact, it reacts with calcium, causing the formation of “soaps” in the baby’s intestines, leading to hard stools and lowered bone mass.

Palm olein is a fat that is high in palmitic acid as well as a source of oleic acid (source). It is often used to mimic the fat profile of human milk, of which the primary fat is also palmitic acid. Here the author’s concerns regarding the addition of palm-based fats to infant formulas are not entirely unfounded. There is some controversy over the use of this ingredient as several published studies (source, source, source) have demonstrated lower fat absorption and lower bone mineral density in infants up to 6 months of age who are fed palm olein-containing formula compared to peers not fed this formula. On the flip side, several other studies note that these differences are still within normal range for normal term infants (source, source) and that these differences likely do not persist once infants start solids and/or become toddlers (source), source). In a nutshell, some differences may exist, but they do not appear to affect a child’s long-term bone mass.

High oleic safflower oil or high oleic sunflower oil: Safflower/sunflower oils are extremely common in packaged foods (read: cheap) are very high in pro-inflammatory omega-6 fatty acids. If these oils are harmful for adults, why would we feed them to babies just after birth?

Similarly to palm olein, high oleic sunflower/safflower oils are added to formula to provide oleic acid, a mono-unsaturated fatty acid present in human milk. Standard versions of these oils are high in omega-6 fatty acids which can be pro-inflammatory and may have an impact on health (though this is generally in context of inadequate omega-3 fatty acid intake, combined with excessive calorie consumption, etc). The high oleic versions are actually quite low in omega-6 fatty acids; 100 mL of standard oil contains 65.7 g poly-unsaturated fat (mostly omega-6), while the high oleic version contains 3.8 g poly-unsaturates per 100 mL (source). The author’s argument here is void. Finally, I would like to return to my much earlier statement that there are many things that adults would not care to ingest, but that does not necessarily make them unsafe for infants.

Choosing the right milk/formula for one’s infant can be stressful and challenging as all parents, including myself, want to do right by our kids and give them the best possible start to life. I do believe that breast milk is fantastic and should be treated as the first choice; I applaud people who go to great lengths to try to give their infants breast milk (through lactation consultants, medications, or milk donors) but these options can be stressful, terribly time consuming, and often expensive, and milk donors are frequently unavailable in most parts of the country. Given this, there are so many reasons why parents may need and/or want to use formula. When it comes to making decisions about infant nutrition, make sure you are consulting qualified sources, including registered dietitians practicing in the area of pediatrics, pediatricians, and infant feeding experts (hint: look for an MD, RD, RN and/or PhD behind the person’s name; if it’s not there, be wary). Infant nutrition is a totally different ball-game from adult nutrition so you want to make sure your sources are truly informed in this area; please exercise caution when taking advice from articles like the one I have referenced.

The infant formulas available today in Canada are safe and proven to produce healthy babies. There is no “healthwashing” about it, and do not let an unqualified person convince you otherwise.

* It should be noted that in cases of cow’s milk protein allergy, soy formulas are not recommended as a standard formula replacement due to the high rate of soy allergy among cow’s milk allergic children. Instead, extensively hydrolyzed cow’s milk formulas (where the protein is highly broken down to the point where it no longer produces allergy symptoms) are recommended.

The fine folks at AllTrials have an important reminder for Canadians who are concerned about clinical trial transparency, and it’s time-sensitive!

We have just heard that we have a chance to improve clinical trial transparency in Canada. Bill C-17 or “Vanessa’s Law” is being considered this Tuesday and there’s a chance to get clinical trial transparency measures added to it.

We urgently need you to write to the MPs on the Standing Committee on Health to tell them how important clinical trial transparency is. A template letter is below, followed by the emails for the MPs on the committee. We’ll keep you posted about the Bill’s progress, but please send your emails today.

They have a sample letter on their website that you can email to the interested parties. Because many of us are also concerned about Vanessa’s Law ignoring potentially-dangerous natural health products, I sent a slightly modified version of the letter, which I’ve included below:

I'm writing to you regarding Bill C-17, known as "Vanessa's Law". I am pleased that Parliament is considering a number of new measures such as the power to recall drugs that will significantly improve patient safety; however, I strongly believe the Bill needs key amendments to fully protect patient safety.

Specifically, it is clear that the bill needs to be amended (1) to require that all clinical trials and observational studies are publicly registered before they begin; (2) to mandate that all trials have their full methods and results reported after completion (preferably within one year); and (3) to include provisions for natural health products (NHPs) to be recalled in the same fashion as pharmaceuticals.

Results from around half of clinical trials have never been published and many have never been registered. New laws in the United States and Europe require the registration and reporting of future clinical trials but in Canada there is no legal requirement to register or disclose the results. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated (at great cost). Further, the regulator's interpretation of the evidence must be publicly available when it approves, refuses or recalls a drug from the market.

Further, it's very important to ensure that information about clinical trials and observational studies is not considered confidential. This information is generated because people participate in trials in the hope of advancing knowledge. If we treat this information as private property, it ignores the contribution that clinical trial participants make.

Finally, it is my understanding that the law currently exempts natural health products (NHPs) from the same level of scrutiny that it applies to pharmaceuticals. To be clear, NHPs are drugs. They are pharmacologically active, they can be dangerous in certain circumstances, and they can have negative drug-drug interactions with pharmaceuticals. For this reason, it is vital that we not exclude NHPs from close scrutiny and potential recall simply because they are "natural".

I understand that Bill C-17, in its current form, lacks these important measures. For this reason, I'm writing to you, in your capacity as a member of the Standing Committee, to urge you to consider amending Bill C-17 to make sure Canada's drug regulatory system is transparent and to ensure that Canadians are protected from all drugs, whether they're "natural" or not. These critical amendments would ensure that the evidence base behind all drugs are open to scrutiny, physicians and other health care providers are adequately informed about the risks and benefits, and patients are better protected from harm.

Sincerely,
Gem Newman
Winnipeg

If you’d like to ensure that medical decisions are based on all relevant evidence (or you’re concerned about the natural health products exemption), I recommend that you take a moment to send a similar email before Tuesday.

Fear sells. Parents are set up to respond to fear-based propaganda quite handily: a new baby in the house puts everyone on alert, like having a delicate glass globe balanced on a knife’s edge, ready to fall at the mere hint of a breeze. The information war over vaccination is an obvious reflection of this fear. Public health has had its hands full during this war, but has failed to really counter the misinformation in vaccine hesitant communities. We are in desperate need for a new message, and a group of high school students from California have made one in a most spectacular way.

On Thursday May 1st, 2014, in Washington D.C., a national launch of a film called Invisible Threat took place for lawmakers in the US. The film was created by high school students at Carlsbad High School in Carlsbad California as a part of a TV and film program called CHSTV. In the past they had produced award winning documentaries written and produced by students on the holocaust and food insecurity and it was after several suggestions from the Rotary Club, a community service organisation, that they acquiesced and made a film about vaccine hesitancy.

According to Lisa Posard, a parent volunteer* at Carlsbad and producer of the film, once the anti-vaccine community got wind of the production through a small news article in a local paper, the threats and emails started and almost stalled their production. At a media call for the film, she confirmed that after the resistance they received from white-supremacists over their holocaust documentary, they considered abandoning the vaccine documentary all together.

The students pushed back, however, and would not give up their investigation. They have since produced a film that has been lauded by the Centre for Disease Control in Atlanta, Every Child by Two and the Children’s Hospital of Philadelphia. The film has become a standard educational tool at 100’s of health-care sites across the US and they are currently searching for a producer to release it commercially. These students will not give up.

It is essential that they do not. With outbreaks of measles and mumps all over North America, the weakness in our defenses against communicable diseases are showing. Measles has a death rate of 1 per 1000 cases and mumps can cause sterility in the teenagers it has afflicted, but this has not stopped the alternative medical establishment from doubling down on their confusing and uninformed campaign against vaccines. Just this week, the Calgary Express interviewed another homeopath who was spreading the bogus autism-vaccine myth and pushing magical potions to prevent dangerous infections instead.

Despite Health Canada’s change to the labelling standard on “homeopathic vaccines” called nosodes, manufacturers continue to push their products as the best way to prevent diseases like the flu. On this website that sells Boiron’s Influenzinum 9C it lists the Health Canada mandated caveat that these products are “not a replacement for vaccines” but at the same time claims that Influezinum is the “best choice as a flu preventative.” The fact that Health Canada continues to allow the sale of these products and refuses to crack down on retailers making these bogus claims is deploring and is another black eye on the face of natural health products regulation in Canada. We need a stronger message.

Producer Lisa Posard and narrator Mark Huckaby at the May 1st launch in D.C.

Invisible Threat delivers just such a message. With interviews from both sides, it shows the devastating effects that vaccine hesitancy can have on a child and a family. We have very good health care in North America, it is true, but children can still succumb to these diseases. Many of the current cases of measles in the US can be traced to importation of the disease from areas where the disease is still rampant and while polio cases have not surfaced in North America, the disease still exists overseas only a plane-ride away.

Dr. Mark Sawyer is a children’s infectious disease specialist from San Diego and was interviewed in the film. He agrees that this threat is real: “There are probably people getting off of planes in America shedding the polio virus,” he said, during the same media call as Posard, “I hope through this film, the next generation of parents will make better decisions than this current generation is making.”

The students from the film worked independently on this project, with no funding or support from the pharmaceutical industry and wrote and directed the film themselves. Despite this, the taunts and threats have continued unabated. “It has been non-stop,” said Posard, “We continue to be affected by these calls.”

Those who mistrust the medical community and the manufacturers of vaccines will not go away. The conspiracy is too juicy and fed by real conspiracies like the burying of data about the risks of smoking or the spread of uncertainty and doubt about climate change by the Koch Brothers and their kin. While the right hides its head in the sand, the left throw sand in the face of corporate science, and the rest of us are left in the middle wondering who is correct – an impossible task for most.

Science can help. While bias does exist and media and special interests, including corporations, spin science messaging to their own advantage, science remains as the best way we have to uncover the truth about the universe. Despite the myth-makers, the spin-addicts, and the conspiracy nuts, cigarette use has gone down, climate science has become even more exact, and vaccines have been shown to be both safe and effective.

The students of Carlsbad High School have shown that the public can have access to the truth, and we should thank them for it.

Errors: Lisa Posard is not a teacher at Carlbad High as stated in the original article but a PTA parent volunteer

The CBC recently aired a “National Check Up” health panel segment ostensibly to discuss the current state of medical research. The panel, led by Peter Mansbridge, consisted of internal medicine specialist Dr. Ali Zentner; Dr. Danielle Martin from Women’s College Hospital in Toronto; and alternative medicine expert Bryce Wylde. Wylde is no stranger to those of us here at Skeptic North, as he has been taken to task more than once. We strongly feel that promoting homeopathy and other forms of quackery is inappropriate at any level, and especially so for such a respected program as ‘The National’.

Here is a An Open Letter to CBC’s Peter Mansbridge from Prof. Timothy Caulfield (republished with permission from Weighty Matters)

Dear Peter Mansbridge:

I couldn’t sleep last night. And it is your fault.

The last thing I watched before I went to bed was The National’s new health panel. And it left me we a deep feeling of despair. I couldn’t shake the sensation that we are slipping into some kind of bizarre all-knowledge-is-relative Dark Age.

The panel has three “experts”, including the terrific and science-based Danielle Martin and Ali Zentner. The third is Bryce Wylde, a self-described homeopathic doctor (he has a diploma from the Ontario College of Homeopathic Medicine) and advocate for, among a host of other scientifically unproven therapies, “natural health” and supplementation.

Now, I don’t know Wylde. He seems like a nice, engaging individual – particularly when he is on Dr. Oz talking about how he “travels the globe in search of Mother Nature’s fountain of youth”. He does this with a mixture of scientific-sounding babble (“vasodilate blood to the brain”?) and everything-natural-is-good boyish enthusiasm. He is, no doubt about it, entertaining.

But including an advocate of homeopathic medicine – one of the most derided and scientifically preposterous of alternative therapies – on a national and highly respected TV news program as a “medical expert” and legitimate source of evidence-based health information is simply wrong. He wasn’t presented as an outsider. His views were not cast as extreme and scientifically questionable. And this was not Dr. Oz, Oprah or an infomercial.

The inclusion of Wylde on this panel is a wonderful (and depressing) example of the phenomenon of false balance. Naturally, it is always good to keep an open mind and to get different perspectives on important issues. I suspect that was the goal the CBC had in mind when they decided to include Wylde. But using a homeopath to comment on biomedical issues is like using an astrologer to balance the views of Stephen Hawking.

I won’t dissect the scientifically questionable comments he made on The National – such as his advocacy of supplements (which he markets on his website – a practice that creates an obvious conflict of interest) and his statements about the health value of organic food. I am more concerned about the impact of putting this perspective on a respected show like The National. It legitimizes pseudoscientific ideas – which may have serious adverse health consequences – and makes it more difficult for the public to differentiate between real and junk science.

The CBC decision is particularly frustrating given that there are so many wonderful, science-based health scholars in Canada, including many who explore the issues associated with and evidence surrounding alternative therapies (such as Drs. Heather Boon at the University of Toronto and Sunita Vohra at the University of Alberta).

So, Mr. Mansbridge, I sincerely hope you look for a different, science-based, commentator for your health panel. I need the sleep.

Timothy Caulfield is a Canada Research Chair in Health Law and Policy and a Professor in the Faculty of Law and the School of Public Health at the University of Alberta. He has been the Research Director of the Health Law Institute at the University of Alberta since 1993. Over the past several years he has been involved in a variety of interdisciplinary research endeavours that have allowed him to publish over 250 articles and book chapters. He is a Fellow of the Trudeau Foundation, a Health Senior Scholar with the Alberta Heritage Foundation for Medical Research and the Principal Investigator for a number of large interdisciplinary projects that explore the ethical, legal and health policy issues associated with a range of topics, including stem cell research, genetics, patient safety, the prevention of chronic disease, obesity policy, the commercialization of research, complementary and alternative medicine and access to health care. Professor Caulfield is and has been involved with a number of national and international policy and research ethics committees, including: Canadian Biotechnology Advisory Committee; Genome Canada’s Science Advisory Committee; the Ethics and Public Policy Committee for International Society for Stem Cell Research; and the Federal Panel on Research Ethics. He has won numerous academic awards and is a Fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences. He writes frequently for the popular press on a range of health and science policy issues and is the author of The Cure for Everything: Untangling the Twisted Messages about Health, Fitness and Happiness (Penguin 2012).

Yoni Freedhoff is a Family physician, Assistant Prof. at the University of Ottawa, Author of The Diet Fix, and founder of Ottawa’s non-surgical Bariatric Medical Institute – a multi-disciplinary, ethical, evidence-based nutrition and weight management centre.

Thanks to Timothy Caulfield and Yoni Freedhoff for permission to re-publish this letter.

Naturopaths are allowed to call themselves doctors in Ontario, placing them alongside Physicians, Dentists, Psychologists, Optometrists, and (regrettably) Chiropractors as a statutorily-legitimized and protected class of healthcare provider.

When someone is given the right to call themselves a doctor, we expect a very high level of medical training and expertise. So it’s fair to ask just what Naturopaths learn during their education. About 2.5 years ago, John did just that, looking at the curriculum of the Boucher Institute in Westminster, BC and finding it riddled with pseudoscience. This article is intended to update John’s work by breaking down the curriculum of the country’s largest naturopathic college, the Canadian College of Naturopathic Medicine (CCNM) in Toronto.

Admission & Program Reqirements

Entry into the CCNM requires at least a 3-year bachelor’s degree in any field of study, a minimum GPA of 2.7 (B-), at least one full year course (6 credits) in each of Biology, Physiology, and Humanities, as well as one half year course (3 credits) in each of Chemistry and Psychology. But for the lack of MCAT scores, this is not dissimilar to the minimum requirements for entry into an MD program, though due to competition, pre-med does tend to be much more rigorous than those minimum requirements. Still, it sets a bar grounded in science, and that’s a good thing.

The program itself is also clearly modelled after Canadian MD programs — two years of academic study, two years of clinical practice, and a two-part certifying exam. The main difference seems to be the lack of a residency requirement, but it’s nonetheless hard to fault ND’s for not putting in the time.

The question, then, is what they’re putting in that time learning. There are three primary areas of study: Biomedical Sciences, Clinical Sciences, and the Art and Practice of Naturopathic Medicine. I won’t cover Clinical Sciences, as it’s mostly about application of the other two, but here’s a breakdown of the rest of the curriculum.

Biomedical Sciences

Coursework in anatomy, physiology, biochemistry, immunology and clinical pathology seems promising. While we can’t be certain of what’s taught in these courses, let’s give CCNM the benefit of the doubt and assume they’re the same as they would be in an MD program, and that they provide a firm grounding in life sciences.

I’m less inclined to grant such leeway to the courses in environmental & public health, given that so many ND’s come out of these programs anti-vaccination, and that alternative medicine has been found to be significantly associated with reduced adherence to vaccine schedules. Yes, there could be self-selection confounding both of these findings, but if this were the case, a science-based curriculum should disabuse students of these biases, and it clearly isn’t. Something seems to be going on in these courses; for further proof, just look at the top titles available in the school’s library. (h/t Scott).

Similarly, the decoupling of courses in pharmacology from those in pharmacognosy (study of natural medicines) is perhaps not surprising, but nonetheless troubling. If a natural medicine works, it does so by pharmacological means, rendering the distinction meaningless — except, that is, to provide ground for the naturalistic fallacy (“natural = safe”) and arguments from antiquity (“old practices = trusted wisdom”) to take root.

Take-away: while there’s likely much science being taught in the biomedical portion of the CCNM program, there are also areas that are likely laced with pseudoscience. When it’s all presented as if it’s “of a piece”, it’s reasonable to be concerned about ND’s ability to tell fact from fiction.

Art and Practice of Naturopathic Medicine

And it only gets worse from there, as the coursework covers the six major modalities of naturopathic medicine:

Homeopathic Medicine – Homeopathy is an elaborate placebo system with no basis in science. That it forms a fundamental part of the naturopath’s curriculum is shameful, and further indication of the casual way in which science is blended with pseudoscience in the curriculum.

Asian Medicine/Acupuncture – covers “Yin and Yang theory, the meridians and channels system, the five-element theory and the symptoms and signs involving the 12 master meridians.” This is pure vitalism, the belief that living things possess an animating energy or life force, and that such energy can be manipulated for therapeutic benefit. In other words, bollocks. Acupuncture in particular has been extremely well studied, and consistently shows no benefit beyond a placebo in the highest quality trials.

Of course it’s fertile. It’s packed in manure.

Botanical Medicine – as discussed above, treating botanical medicines as different from other medicines is an artificial distinction that only serves the naturalistic fallacy. Nature of course produces many useful compounds, but unfortunately they’re only occasionally safe enough and effective enough to be useful in their native form.

Health Psychology and Lifestyle Counselling – not much to say here, other than presumably the counseling includes guidance in applying the other 5 modalities.

Take Away: any good done by the science courses in the biomedical track is completely undone by training in naturopathic modalities. If there’s a pseudoscientific treatment out there, it’s probably taught at the CCNM.

The Statutory Whitewash

Even if we accept the basic notion that natural treatments are somehow better than other medical treatments, the presence of homeopathy, detoxification, and energy therapies in the Canadian College of Naturopathic Medicine’s curriculum is a healthcare travesty. Though CCNM’s ND program is structurally modeled after Canadian MD programs, its substance is so divorced from reality as to render its graduates incapable of science-based practice. That they’re allowed to call themselves doctors is a testament to a flawed regulatory structure, not the training standards of the profession.

Another foreign government report has been released concluding that homeopathy is worthless.

The UK government [pdf] concluded that homeopathy was no better than placebo. The Swiss even threw them a bone and lowered the standard of evidence for the review and came to the same conclusion. Now the Australian government [pdf] has completed its review and concluded the same thing.

So would Health Canada like explain why it continues to give homeopathic products NHPD approvals and exemptions to be sold to Canadian citizens even though the product numbers are assigned to chemically indistinguishable placebos?

Health Canada continues to shame itself by failing to even remotely approach the level of work that other governments have done. There is zero justification for Health Canada to continue approving these products on the Canadian dime and it is ethically appalling that this continues, even under the banner of so-called consumer freedom.

Chili’s (a restaurant chain, for those who aren’t already familiar with their earworm baby back ribs song) came under fire this weekend for a promotion in which they would donate a percentage of money from purchases today (7 April 2014) to an autism charity called the National Autism Association.

Unfortunately for Chili’s awareness campaign, they apparently were not aware that the NAA promotes the unsupported hypothesis that vaccines are a possible cause of autism. From the NAA website:

The National Autism Association believes:

Vaccinations can trigger or exacerbate autism in some, if not many, children, especially those who are genetically predisposed to immune, autoimmune or inflammatory conditions.

Other environmental exposures may trigger, or exacerbate, autism in certain children, especially those who are genetically predisposed to immune, autoimmune or inflammatory conditions.

They also say:

Based on parent reports – including parents representing the National Autism Association – sharp regression occurred in their children directly following immunizations. … Though published mainstream science fails to acknowledge a causal link to any of these specific exposures, it’s important that parental accounts be carefully considered.

And though their statements above are middling at best to outright wrong at worst, this is the nail in the coffin:

If you are a parent seeking detailed information on vaccine safety, we recommend visiting the National Vaccine Information Center [link removed] website.

The NVIC is a known anti-vaccination organization. There is no scientific basis for the claims made by the NAA or NVIC. There is no evidence that vaccines can trigger autism in any child. Though subjective reporting can be helpful in situations where scientific data is limited as a starting point to investigate apparent issues, the autism/vaccine “link” is not one of those cases. There is an abundance of scientific research that fails to show a link between vaccines and autism.

This information was pointed out to Chili’s and today they announced that they were canceling their promotion in the following statement:

Chili’s is committed to giving back to the communities in which our guests live and work through local and national Give Back Events. While we remain committed to supporting the children and families affected by autism, we are canceling Monday’s Give Back Event based on the feedback we heard from our guests.

We believe autism awareness continues to be an important cause to our guests and team members, and we will find another way to support this worthy effort in the future with again our sole intention being to help families affected by autism. At Chili’s, we want to make every guest feel special and we thank all of our loyal guests for your thoughtful questions and comments.

Kudos to Chili’s for responding to public pressure that was, refreshingly, in the right for a change. Though some would say otherwise:

The medical mafia is alive and well in America today, where pro-vaccine thought police routinely engage in malicious campaigns to smear anyone who dares ask the question “Are vaccines linked to autism?”

When Chili’s recently announced they would make a one-day gesture to provide financial assistance to families devastated by autism, even that was too much for the medical mafia. Their operatives fanned out across the mainstream media to disparage Chili’s for even daring to help autistic children. The danger of people becoming merely “aware” of autism is so great, it seems, that even a goodwill effort to help support mothers of autistic children must be stifled and shut down as quickly as possible.

Fun game: Go on and guess who that was before following the link… Yeah, who else would say “medical mafia”?

We can continue along a path of folly and wasted time and effort, or we can move on and try to find the actual cause (or causes) and therefore potentially discover effective treatments for those whose autism comes with limitations to independence and quality of life. I hope Chili’s still donates some money for autism awareness month, but to a reputable organization that doesn’t also unnecessarily throw vaccines under the bus.

This week, the Royal Society of Canada released a report by their Expert Panel on Safety Code 6. Safety Code 6 is the Health Canada standard that sets recommended exposure limits for radio-frequencies. The last update was in 2013, and Health Canada wanted the RSC’s advice on the updates to make sure they were up to scientific snuff. Many news outlets reported the fact that the panel recommended that “more research was needed” but the media downplayed the stronger message in the report: SC6 meets international standards and is agreement with the science as it now stands. “More research is needed” is a misunderstood phrase in the public form and needs some discussion, as does the findings of the RSC’s new report.

“More research is needed” is an almost automatic phrase in the conclusions of most scientific studies. It is not only there to justify a continuation of a scientist’s research programme, it also reflects the current understanding of our knowledge. Einstein’s revolutionary concept of relativity caused scientists to admit almost a century ago that our knowledge of the world is not absolute. Newton’s laws had been considered universal and absolutely true up until the end of the 19th century. Einstein’s update proved this wrong and since then we have been forced to change our thinking of the world.

This does not mean, however, that science is just an opinion like a movie review or sports commentator: science has rules. Granted, they change from time to time based on new information, but these rules help us decide what facts to accept as knowledge: facts that are true, or connected to the real world. We have relied on these rules to push our society forward and solve many problems and it is a pretty good solution, one of the best we have, really. But it is flawed, and it is at these stress points where attacks on science occur.

Scientists have ceased giving black-and-white answers since then. In our current method, we make a guess called a hypothesis and try to answer the question about its truth. If we gather enough evidence, through calculation or observation, we turn our guesses into theories: models of the world. Therefore a scientific theory, rather than giving us a collection of facts, points in the direction of a conclusion about the truth of the real world. Sometimes that conclusion is strong, like the conclusions of the theory of evolution. Sometimes the conclusions are weak, like the notion that coffee causes cancer.

While we rarely find changes in direction of the theory of evolution, we seem to change our mind often about things like what causes cancer. The question is hard, and complicated, and is affected by many different factors. In both these situations it is obvious why more research is always needed: we are never at our destination, we are only looking at the sign pointing there.

That is why we have “more research is needed” in the RSC paper on SC6. Causes of cancer are hard to discern, and it is still inconclusive as to whether the weak association that has been seen between cell phone use and cancer is real, or if it is just a result of “noise” in a study that is difficult to conduct. Even in the area of IEI-EMF or electromagnetic-hypersensitivity, we have very conclusive evidence that RF does not cause the symptoms, but we don’t have a reason why we have a group of people who report sometimes debilitating conditions. The RSC recommended that we need more research to help answer both of these questions and we may always need more research; that is the constant state of science.

We are therefore left in the difficult position to draw conclusions anyway using the information we have. Humans need answers, and we have developed short-cuts in thinking to draw conclusions despite having incomplete evidence. One common cry among critics is that they want definite assurance that a technology is safe before allowing its general use. One look at our fallibility statement above and it becomes obvious why this question can never be answered by science. Science makes a guess then tries to find evidence that it is true. We will never be able to say 100% that a tech is safe; it just is not possible, so more research will always be necessary to continue to look for unwanted effects; to human health or otherwise. It’s along the same lines that the SC6 panel was considering “established adverse health effects” defined here:

The Panel considered an “established adverse health effect” as an adverse effect that is observed consistently in several studies with strong methodology.

Not surprisingly, the panel found none. Using very high evidence standards, represented by the several pages of references (including the bad science of the Bioinitiative report), the panel found that the overwhelming evidence is that RF does not cause any adverse health effects. All the signs point toward cell phones and other wireless devices being a safe technology as long as they operate within the SC6 standards. This does not mean that we should not pursue adverse effects in the future. Rather, we should encourage those researchers trying to identify any changes that cells and organs undergo in the presence of the low level RF capped by SC6. What is most likely, given all of the evidence, is that these effects are going to be very small and the risks low.

The report also recommends that Health Canada develop a better communications strategy to tell the Canadian public about the effects and any risks associated with this tech. In a society that is increasingly risk-averse, we obsess about an unsubstantiated risk of cell phones for cancer while ignoring the risks of other technology, like cars (there were 2000 pedestrians killed between 1988 and 2002 in Ontario). These fears are being inflamed by groups who ignore the balance of evidence in favour of a few studies that agree with their ideology. They have the ear of media, and we need to counter their conspiracies.

When pondering the risks of cell phones, consider this: we have all been bathed in the emissions from radio and television for close to a hundred years, and in that time our life expectancy has continued to increase. Even more, since the dawn of life on the planet we have been bathed in the constant radiation from the sun including radio-waves. Since the dawn of time we have even been awash in the radiation from the Big Bang: the cosmic microwave background. We need to take a step back from the rhetoric and let science be our guidepost to the truth, not our fears.

In 2011, I wrote an evaluation of a migraine treatment product that was just beginning to move across the Atlantic from Europe. Cefaly is a headband that delivers electrical stimulation externally to the major occipital and transgeminal nerves. The idea is that transcutaneous nerve stimulation can have similar results reported for more invasive treatments. However even the careful placement of electrodes directly on the nerves, while promising, is still in early stages of development. The reason for this second look at Cefaly is a news release from the US Food and Drug Administration announcing that STX-Med is now allowed to market their product in the US.

For Immediate Release: March 11, 2014 Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA allows marketing of first medical device to prevent migraine headaches Today, the U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain. “Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.” Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound. A migraine can last from four to 72 hours when left untreated. According to the National Institutes of Health, these debilitating headaches affect approximately 10 percent of people worldwide and are three times more common in women than men. Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears. The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode. The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied. Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes. The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium. The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur. The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session. No serious adverse events occurred during either study. Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium. For more information: FDA: Medical Devices NIH: NINDS Migraine Information Page

The important thing to note here is that Cefaly has been approved through the “de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices”. The safety study referenced by STX-Med for approval involved over 2,000 patients of which only 4.3% reported any adverse reactions, all of which were mild and reversible following discontinuation of treatment. This study did not examine the effectiveness of the headset in any way other than a vague outcome of ‘patient satisfaction’.

The study that did involve efficacy had only 67 patients in the trial, but some of the outcomes showed promise. The researchers compared sham neurostimulation against the standard Cefaly stimulation. There was no control without a device.

The STS generates biphasic rectangular impulses with an electrical mean equal to zero and the following characteristics: pulse width 30 µs for sham and 250 µs for verum, frequency 1 Hz for sham and 60 Hz for verum, maximum intensity 1 mA for sham and 16 mA for verum. The daily sham or verum neurostimulation sessions lasted 20 minutes.

Patients maintained a diary and recorded headache frequency and severity.

Primary outcome measures were 1) change in monthly migraine days between the run-in month and the third month of treatment; and 2) percentage of “responders,” i.e., of subjects having at least 50% reduction of monthly migraine days between run-in and third month of treatment.

Secondary outcome measures were 1) change in monthly migraine days between run-in and the average 3 months of treatment; 2) change in monthly migraine attack frequency; 3) change in monthly frequency of any headache; 4) change in mean headache severity per migraine day; 5) change in monthly acute antimigraine drug use and in associated symptoms per migraine headache between run-in and third month of treatment; and 6) percentage of patients stating at the end of the trial that they are very satisfied, moderately satisfied, or not satisfied with the treatment.

My statistics are rusty, but the number of total comparisons would increase the possibility of a false positive, and the inclusion of study dropouts using data up to the time they left the study seems questionable to me. Perhaps someone with a grasp of the relevant stats could leave a comment to help clarify the appropriateness of the analysis.

There were a number of reasons that patients were excluded from the study:

In the end, the number of migraines was decreased in the active treatment group, as was the amount of medication required. There was also an increase in the number of patients who reported a 50% decrease in attacks.

A third study describing the sedative effect of Cefaly used a slightly different protocol in an attempt to control for the patient’s ability to sense the electric current by using controls and sham neurostimulation.

We performed a double-blind crossover sham-controlled study of 30 subjects to assess the effect on vigilance of different protocols of supra-orbital TNS. Each subject was tested in 4 different experimental conditions: without neurostimulation device (blank control: BC), with a sham neurostimulation (Sham control: SC), with a low frequency neurostimulation (LFN) and with a high frequency neurostimulation (HFN)

Results are compatible with decreased vigilance and arousal studies, but show no indication of inducing or improving sleep. Sedation may help some patients with migraine, but decreased arousal during sleep has been associated with sufferers.

The primary Cefaly site lists only the 3 studies described here, while the Canadian site, at least at the time of this writing, still contains the entire list of irrelevant studies with the misleading headings I discussed in my previous article. I’m not going to comment on the testimonials except to say that my degree of skeptism of any treatment is directly proportional to the number of testimonials used in advertising.

These studies show the possibility of Cefaly as a partial prophylactic for some types of migraines, but but no indication it is useful as a treatment for an ongoing attack.

So, the question remains, is Cefaly worth the price? The cost on the Cefaly Canada site is $349.00 + taxes and shipping (total=$388.49). A pack of 3 extra electrodes is $24.99 ($31.49 total). Each electrode is supposed to last for 15-30 uses, so the additional cost of the electrodes could be anywhere from $127 to $255 per year. Cefaly seems to be well tolerated by most users, at least in the short term. However, it is not an insignificant cost for something that may have no effect at all. It would be interesting to see how many people are still using it 3 or 4 years later.

The decrease in requirement for medication is intriguing on a cost basis, and also the potential for limiting the possible side-effects. There is a wide range of medications used to treat migraines, and each comes with it’s own side-effect profile; a fairly comprehensive list can be found on the Rx List site. As the study above noted, Cefaly is not considered a useful treatment for an ongoing attack, so for those who require acute treatment, medication will not be eliminated. Cefaly is also much less invasive than implanted electrodes, and it might be worth considering before undergoing surgery.

Migraine is a complex disorder with varied triggers and there is no single treatment that could ever hope to eliminate all attacks, and I do understand that for anyone who suffers from chronic pain that any hope can be worth a try and it appears that the risks of using Cefaly are mostly financial. It is possible that Cefaly might help any given individual, but each person should take these and other aspects into consideration.